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Patendinõudlus eluteaduste valdkonnas

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Eluteaduste valdkonna intellektuaalse omandi kaitse . Patendiotsing, patendinõudlus.

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Patendinõudlus eluteaduste valdkonnas

  1. 1. Eluteaduste valdkonna intellektuaalse omandi kaitse Patendiotsing, patendinõudlus Margus Sarap, Euroopa patendivolinik 17.aprill 2013, Tartu Biotehnoloogia Park
  2. 2. Biotehnoloogia erisused? 4/2/2013 2Margus Sarap, 2013
  3. 3. Mittepatenditavad: bioloogilisi meetodeid bioloogilise aine, taime või looma saamiseks välja arvatud mikrobioloogilised meetodid mikroorganismide saamiseks leiutised, mida saab kasutada ainult ühe kindla taimesordi või loomatõu puhul NB! Bioloogilise aine, taime või looma saamise olemuselt bioloogiline meetod on meetod, mis täielikult põhineb looduslikul nähtusel, nagu ristamine ja selektsioon. Biotehnoloogia erisused? 4/2/2013 3Margus Sarap, 2013
  4. 4. NB! Ühe ja sama patenditaotlusega saab taotleda patendikaitset ainult ühele leiutisele või ühtse leiundusliku mõttega seotud leiutiste kombinatsioonile Biotehnoloogia erisused? 4/2/2013 4Margus Sarap, 2013
  5. 5. Biotehnoloogia erisused? 1. A fluorescent probe for determining protein kinase activity with the general formula (I): (X-Y-Z)-L-F (I), wherein X-Y-Z is a bisubstrate-analog inhibitor of a protein kinase, in which X is a compound that binds to the ATP-binding pocket of the kinase and; Z is a compound that binds to the protein/peptide-binding domain of the kinase; Y is a an organic tether that connects X and Z and permits simultaneous binding of X and Z to the active site of the kinase; F is a fluorescent dye which optical characteristics are changed in the course of the binding of (X-Y-Z)-L-F to the kinase; L is a linker (between the bisubstrate-analog inhibitor XYZ and fluorescent label F) formed of a hydrocarbon chain, of other type of organic molecule or of part of organic molecule; may be omitted in the probe and F directly bound to inhibitor XYZ. 4/2/2013 5Margus Sarap, 2013
  6. 6. Biotehnoloogia erisused? 1. A fluorescent probe for a protein kinase selected from the group consisting of: 2. A kit comprising a fluorescent probe of claim 1. 3. A bisubstrate-analog inhibitor of a basophilic protein kinase selected from the group consisting of: 4. A method for determining the fraction of an active binding form of a protein kinase in a sample containing a fluorescent probe of claim 1 ... N O N N OHOH N NH2 O N O N + -OOC O NH O NH-(D-Arg)6 -(D-Lys)-C(=O)-NH2 NH N S OO HN N H O NH-(D-Arg)6-D-Lys(5-TAMRA)-C(O)NH2 N O N N OHOH N NH2 O O NH-(D-Arg)6-(D-Lys)-C(=O)-NH2 N NO O2 N N H NH N O N N OHOH N NH2 O N O N + -OOC O NH O NH-(D-Arg)6 -(D-Lys)-C(=O)-NH2 NH N S OO HN N H O NH-(D-Arg)6-D-Lys(5-TAMRA)-C(O)NH2 N O N N OHOH N NH2 O O NH-(D-Arg)6-(D-Lys)-C(=O)-NH2 N NO O2 N N H NH 4/2/2013 6Margus Sarap, 2013 patent US8,158,376
  7. 7. Patendidokumendi ülesehitus? •Leiutiskirjeldus – specification –Pealkiri - Title –Tehnika valdkond – Technical Field –Tehnika tase – Background Art –Leiutise olemus – Summary of invention –Jooniste loetelu – Brief description od drawings –Teostusnäi(de)ted – Description of embodiments –Viited – Recitation list –Patendinõudlus - Claims –Lühikokkuvõte - Abstract –Joonised - Drawings 9.12.2011 7Sarap ja Partnerid, ©2011
  8. 8. Patendidokumendi erinevate osade tähendu Kõige tähtsam – patendinõudlus tehnilise lahenduse (leiutise) kaitseulatus sõltumatu punkt sõltuvad punktid 9.12.2011 8Sarap ja Partnerid, ©2011
  9. 9. Patendidokumendi erinevate osade tähendus? Leiutiskirjeldus leiutise olemuse avamine tehnilise lahenduse täpne kirjeldus 9.12.2011 9Sarap ja Partnerid, ©2011
  10. 10. Vähiravi Explanation of terms •Heat shock protein 90 (HSP 90) Belongs to a class of proteins that protect cells when stressed by elevated temperatures; assists in tumour repression. •Heat shock protein 90 inhibitor (HSP 90 inhibitor) Compounds which block the functioning of HSP 90. Examples: geldanamycin or 17-alkylamino- 17-desmethoxygeldanamycin (17-AAG). •Platinum coordination complexes Platinum complexed with ligands. These compounds are used as chemotherapeutics. Examples: cisplatin, carboplatin, oxaliplatin. 17-AAG, R17 = alkylamino Oxaliplatin Allikas EPO materjalid , nõudluse tõlgendamine
  11. 11. Leiutis An improved way of treating people suffering from breast cancer by injecting a platinum coordination complex and optionally also an HSP 90 inhibitor. The invention shows improved results by combining the two compounds. The specific combination of oxaliplatin and 17-AAG has a synergistic effect. How can you protect it from imitation? • "An improved way" → Compared with what? (term not clear) • "Way of treating people" → Method of treatment of the human or animal body by therapy = excluded from patentability • "A platinum coordination → Not a "method of treatment"; has a complex " technical function → possible patent Allikas EPO materjalid , nõudluse tõlgendamine
  12. 12. Patent Claim: "A platinum coordination complex" How to patent this invention: claim it! Claiming a platinum coordination complex in general means trying to get very broad protection. You already know that such complexes have been described before. Patent Claim: "A platinum coordination complex for use in the treatment of suffering people." This wording also does not describe what you invented. Patent Claim: "A platinum coordination complex for use in the treatment of breast cancer." A prior art search will show whether the invention – as claimed – is actually new. Allikas EPO materjalid , nõudluse tõlgendamine
  13. 13. Tehnika taseme otsingu tulemused The prior art search found a journal article that discloses the invention. Cancer Treatment Reports 67(3) 235-238, 1983 "... 2 [patients] with adrenocarcinomas in the breast ... were treated with cisplatin at a dose of 60 mg/m2 ..." A platinum coordination complex (i.e. cisplatin) for use in the treatment of cancer is already known from this journal article! Allikas EPO materjalid , nõudluse tõlgendamine
  14. 14. Comparison of the two inventions The invention as claimed Cancer Treatment Reports "A platinum coordination complex for use in the treatment of breast cancer." "... 2 [patients] with adrenocarcinomas in the breast ... were treated with cisplatin at a dose of 60 mg/m2 ..." "A combination of a platinum coordination complex and an HSP 90 inhibitor for use ..." • New • Inventive step (the combined use shows improved effects) Allikas EPO materjalid , nõudluse tõlgendamine Not new
  15. 15. Leiutist kaitsev nõudlus Claim to be filed: "A combination of a platinum coordination complex and an HSP 90 inhibitor for use in the treatment of breast cancer." Allikas EPO materjalid , nõudluse tõlgendamine
  16. 16. Sõltumatute nõudluste kasutamine kaitse täiendamiseks The patent should include both broad and specific claims. Broad: An independent claim (i.e. a claim stating the essential features of the invention) helps prevent the patent from being circumvented. Specific: Dependent claims refer to an independent claim and additionally define preferred embodiments of the invention. Independent claim Dependent claim 1 Dependent claim 2 Allikas EPO materjalid , nõudluse tõlgendamine
  17. 17. Patendiametile (EPO) esitatud taotlus CLAIM 1: "A combination of a platinum coordination complex and an HSP 90 inhibitor for use in the treatment of breast cancer." Claim 2: "A combination according to claim 1, characterised in that the HSP 90 inhibitor is 17-AAG." Claim 3: "A combination according to claim 1, characterised in that the platinum coordination complex is oxaliplatin." The patent office will perform its own prior art search and then consider whether the invention AS CLAIMED is new and non-obvious. Claim 4: "A combination according to claim 2, characterised in that the platinum coordination complex is oxaliplatin." Allikas EPO materjalid , nõudluse tõlgendamine
  18. 18. Tehnika tase EPO otsingust "Combination of HSP 90 inhibitor ... with anticancer agents like carboplatin or cisplatin ... to inhibit ... growth of breast cancer cells." "Methods for enhancing the efficacy of cytotoxic agents through the use of HSP90 inhibitors"
  19. 19. EPO arvamus Applicant's claim: "A combination of a platinum coordination complex and an HSP 90 inhibitor for use in the treatment of breast cancer." The invention according to claim 1 is already shown and claimed in WO 02/15925. EPO response: Please amend your claims if you want your invention patented! A platinum coordination complex (e.g. cisplatin) and an HSP 90 inhibitor were used in WO 02/15925 to treat breast cancer.
  20. 20. Edasine analüüs •Check the material revealed in the prior art searches: • Does the invention have any features NOT disclosed in the prior art? • What are the advantages of the invention compared with the prior art? How can the claims be amended to reflect the invention in a way that it is new (considering all the prior art)? •Did the EPO interpret any important features of the invention differently to the inventor? Applicant's reply: amendments to the application, explanation of the relationship between the invention and the prior art
  21. 21. Synergism (more than additive) Claim 2: Features of Claim 1 + HSP90 inhibitor = 17-AAG Claim 4: Features of Claims 1 + 2 + Pt coordination complex = oxaliplatin Cancer Treatment Reports Improved effect (additive) Claim 3: Features of Claim 1 + Pt coordination complex = oxaliplatin Claim 1: Combination of HSP 90 inhibitor and Pt coordination complex Leiutise võrdlus tehnika tasemega Technical features of the invention WO 02/15925 Advantages/technical result No No No No No No No No No No
  22. 22. Analüüsi tulemus Although the individual elements of the invention are known, the combination of specific compounds is not and it produces a new, unique benefit. But you have to take into account that: Claim 2 refers to the use of 17-AAG. To use this specific HSP 90 inhibitor is considered to be trivial, because WO 02/15925 recommends using any HSP 90 inhibitor in combination with an anticancer agent. Claim 3 teaches the use of oxaliplatin. Again, since WO 02/15925 hints at the use of any anticancer drug, the use of oxaliplatin is also considered to be obvious. Claim 4 describes the use of the combination of oxaliplatin and 17-AAG. It is shown in the patent application that the combination produces a synergistic (= more than additive) effect. This is not disclosed in WO 02/15925.
  23. 23. Analüüsi tulemused If one compound is simply replaced by another without showing any unexpected or surprising effect, such a replacement is frequently considered to represent routine for an expert. If an unexpected or surprising effect can be shown, then the invention is often considered to be inventive (i.e. the invention is not obvious for an expert working in the technical field). The use of 17-AAG and oxaliplatin, which leads to an unexpected synergistic combination, is therefore inventive. Invention (new + inventive) R17 = alkylamino
  24. 24. The present invention provides a method for treating cancer. The method involves the administration of an HSP90 inhibitor and a platinum coordination complex, where the combined administration provides a synergistic effect. The HSP90 inhibitor for this aspect is typically 17-AAG, while the platinum coordination complex is oxaliplatin. 17-AAG combination in SKSBr-3 cells [0093] The following table provides CI values for combinations of 17-AAG and the platinum complexes oxaliplatin and cisplatin in an SKBr-3 cell assay ... EPOsse esitatud kirjeldus toetab parandusi Different to "Cancer Treatment …" Different to patent WO02/… Supports inventive step: different technical result
  25. 25. Väljaantud patendi nõudlus Claim 1 as granted reads: "Medicament comprising 17-Alkylamino-17-desmethoxygeldanamycin (17-AAG) and oxaliplatin for use in the treatment of breast cancer in a patient." Response from EPO: granted!
  26. 26. EP1179050 •1. A method for removal of protein kinase from a liquid containing the protein kinase by contacting the liquid with a carrier bound affinity ligand for the kinase, characterized in that the ligand is a bisubstrate inhibitor for the kinase whereas the ligand is attached to the carrier. •2. The method of claim 1, characterized in that the bisubstrate inhibitor comprises the structure •C-(L) n-N •where •(a) C contains a structure inhibiting binding of the peptide/protein substrate to the protein kinase, •(b) L is an organic linker, •(c) n is an integer 0 or 1, and •(d) N is an inhibitor competitively inhibiting binding of the nucleoside triphosphate (NTP) to the protein kinase; •and the structure is attached to the carrier via C. •3. The method of any one of claims 1-2, characterized in that C is a peptide substrate consensus sequence or a pseudosubstrate consensus sequence.4/2/2013 Margus Sarap, 2013 26
  27. 27. Näide 4/2/2013 Margus Sarap, 2013 27 • 1. A method for removal of protein kinase from a liquid containing the protein kinase by contacting the liquid with a carrier bound affinity ligand for the kinase, characterized in that the affinity ligand is a bisubstrate inhibitor having a structure containing • - a moiety having the structure that is able to competitively inhibit binding of the relevant nucleotide triphosphate (NTP) and • - a moiety having the structure that is able to competitively inhibit binding of peptide or protein substrate • to the particular protein kinase molecule whereas the ligand is attached to the carrier. • 2. The method of claim 1, characterized in that the bisubstrate inhibitor for the particular protein kinase molecule comprises the structure • C-(L) n-N • where • (a) C contains a structure inhibiting binding of the peptide or protein substrate to the protein kinase, • (b) L is an organic linker, • (c) n is an integer 0 or 1, and • (d) N is an inhibitor competitively inhibiting binding of the nucleoside triphosphate (NTP) to the protein kinase. • 3. The method of any one of claims 1-2, characterized in that C is a peptide substrate consensus sequence or a pseudosubstrate consensus sequence.
  28. 28. • 1. A method for removal of protein kinase from a liquid containing the protein kinase by contacting the liquid with an affinity ligand for the kinase bound to a carrier insoluble in aqueous media, characterized in that the affinity ligand is a bisubstrate inhibitor having a structure containing simultaneously • - a moiety having the structure that is able to competitively inhibit binding of the relevant nucleotide triphosphate (NTP) and • - a non-phosphorylatable moiety having the structure that is able to competitively inhibit binding of peptide or protein substrate • whereas both moieties target the particular protein kinase molecule whereas the ligand is attached to the carrier. • 2. The method of claim 1, characterized in that the bisubstrate inhibitor for the particular protein kinase molecule comprises the structure • C-(L)n-N • where • (a) C contains a structure inhibiting binding of the peptide or protein substrate to the protein kinase, • (b) L is an organic linker, • (c) n is an integer 0 or 1, and • (d) N is an inhibitor competitively inhibiting binding of the nucleoside triphosphate (NTP) to the protein kinase. • 3. The method of any one of claims 1-2, characterized in that C is a peptide substrate consensus sequence or a pseudosubstrate consensus sequence. 4/2/2013 Margus Sarap, 2013 28
  29. 29. 4/2/2013 Margus Sarap, 2013 29 Claims 1. A method for removal of protein kinase from a liquid containing the protein kinase by contacting the liquid with an affinity ligand for the kinase bound to a carrier insoluble in aqueous media characterized in that the affinity ligand is a bisubstrate inhibitor having a structure containing simultaneously - a moiety having the structure that is able to competitively inhibit binding of the relevant nucleotide triphosphate (NTP) and - a non-phosphorylatable moiety having the structure that is able to competitively inhibit binding of peptide or protein substrate whereas both moieties target the particular protein kinase molecule whereas the ligand is attached to the carrier. 2. The method of claim 1, characterized in that the bisubstrate inhibitor for the particular protein kinase molecule comprises the structure C-(L)n-N where (a) C contains a structure inhibiting binding of the peptide or protein substrate to the protein kinase, (b) L is an organic linker, (c) n is an integer 0 or 1, and (d) N is an inhibitor competitively inhibiting binding of the nucleoside triphosphate (NTP) to the protein kinase. 3. The method of any one of claim 2, characterized in that C is a peptide substrate consensus sequence or a pseudosubstrate consensus sequence.
  30. 30. Nõudlused kellele •taotleja -> võimalikult lai kaitse •Patendiameti ekspert -> tehnika tase -> kitsendamine •konkurent • patendi vaidlustamine’ • rikkumine •rikkuja 4/2/2013 Margus Sarap, 2013 30
  31. 31. EE03157 •1. Optiliselt puhas ühend, mida iseloomustab see, et ühend on (-)-5-metoksü-2-{[(4-metoksü-3,5- dimetüül-2-püridinüül)metüül]sulfinüül]-H- bensimidasooli Na+ -, Mg2+ -, Li+ -, K+ - Ca2+ - või N+ (R)4- sool, milles R on alküülrühm 1-4 süsinikuaatomiga. 4/2/2013 Margus Sarap, 2013 31 Küsimused? -Mis on optilise puhtuse määr -tehnika tasemest tuntud Na, Mg soolad
  32. 32. Küsimused? Sarap ja Partnerid Patendibüroo Margus Sarap patent@patent.ee tel 747 7058 Kompanii 1c, Tartu Mikk Putk mikk.putk@patent.ee tel 53 039 088 Soo 46, Tallinn 4/2/2013 32Margus Sarap, 2013 www.patent.ee

Editor's Notes

  • Definition of the terms used in the example. Note: While real patents have been used in this case study, the various steps in the procedure followed by the applicant/attorney have been adapted for the purpose of this presentation.
  • You have two options for defining your invention: 1. Pt coordination complex only = normal chemotherapeutic agent 2. Combination of Pt coordination complex with HSP 90 inhibitor How can you protect it from imitation? - Three ways of defining claims, with an explanation as to why these ways are suitable/unsuitable. - Exceptions to patentability: No patents shall be granted in respect of methods for the treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body (Article 53(c) EPC).
  • Note: The product was formulated as a second medical use (EPC 2000), but this aspect will not be covered in this presentation. You should carry out a prior art search BEFORE you start researching or drafting your claims.
  • Cisplatin is used as a chemotherapeutic agent, so this document is novelty-destroying.
  • Analysis of features and comparison with the prior art: the combination of a Pt coordination complex and an HSP 90 inhibitor was not disclosed in Cancer Treatment Reports.
  • This is the first draft of an independent claim relating to the invention.
  • Applications are normally structured to include both independent and dependent claims. The independent claim describes your invention in very general terms, to allow a broad interpretation in any infringement lawsuits. The dependent claims describe specific ways to put the invention into practice. They often describe the most commercially successful embodiments of the invention. For example an independent claim 1 could read: "A writing instrument comprising two chambers which are linked by a hole." A dependent claim could read: "The writing instrument of claim 1, characterised in that its length is between 10 and 15 centimetres."
  • This slide looks in more detail at the two kinds of claims referred to in the previous slide (Rule 43(3) EPC): Claim 1 = independent claim An independent claim states the essential features of the invention. In our example this means: a combination of a first compound (= platinum coordination complex) with a second compound (= HSP 90 inhibitor) and the use of this medicament (= treatment of breast cancer) Claims 2-4 = dependent claims Dependent claims define particular embodiments of the invention, i.e. since they refer to other claims, they relate to a combination of the essential features of the invention (of the independent claim) together with one or more further features. e.g. claim 2 refers to claim 1 and therefore relates to the features of claim 1 in combination with a further feature, which is that the HSP 90 inhibitor is 17-AAG. The same applies to claim 3, since this claim also refers to claim 1. It therefore relates to a combination of the features of claim 1 with a further feature, which is that the platinum coordination complex is oxaliplatin. Note : Claim 4 has the same wording as claim 3, but refers to claim 2! This means that claim 4 relates to a combination of the features of claims 1 and 2 and additionally states that the platinum coordination complex is oxaliplatin.
  • The prior art found by the EPO is in Chinese. Does this matter? No, because the state of the art comprises everything made available to the public by means of written or oral description, by use or any other way before the filing date of the European patent application (Art.54(2) EPC). The language itself is not relevant. Examples of prior art disclosure (provided they were made available to the public prior to the filing date of the European patent application): a journal article written in Hindi a lecture to students at a university a presentation at a congress the marketing of a product a disclosure on the internet (provided the publication date can be proven beyond any doubt) a book Examples which do not constitute prior art disclosure: a presentation given to a group bound by a confidentiality agreement (not public!) a journal article published four years after the filing date of the European patent application (not published before the filing date)
  • Comparison of the disclosure of the prior art document with the proposed claim(s).
  • Questions to be asked by the applicant prior to filing an amended set of claims.
  • Although the subject-matter of claims 2-4 is novel, no inventive step can be found in claims 2 and 3.
  • Comparison of the effects achieved by the subject-matter claimed with those of the available prior art.
  • Explanation of the inventive step.
  • Green: The European patent application must not be amended in such a way that it contains subject-matter which extends beyond the content of the application as filed (Article 123(2) EPC). In other words, all amendments must be based on the content as disclosed right from the filing of the patent application. Example: Where a patent application relates on the date of filing exclusively to a composition for use in the treatment of breast cancer, it will not be possible during the examination procedure for this application to claim the composition for use in the treatment of headache. Red: Differences between the prior art document found by the patent attorney and the present patent application. Yellow: Differences between the prior art document found by the EPO and the present patent application
  • Final version of claim 1.
  • ×